Movement Quality and Balance Improvement in People With Chronic Low Back Pain Following Trunk Muscle Training

NCT06944730 | Recruiting

• 2 other identifiers: HongKongPU RS2022.176
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this project is to assess if Chronic Low Back Pain (CLBP) participant's movement quality and balance variables can change after training that decreases their pain and disability. It will also compare the difference between structural exercise (SE) and isolated trunk exercise (ITE). The main questions it aims to answer are:

1. 1.What are the effect of the training on the participant's movement quality and balance.
2. 2.What are the difference between different types of trunk muscle training on people with CLBP.
3. 3.Do home and in-lab based SE or ITE training, or maintain active daily living over 2 months.
4. 4.Complete the pain and disability questionnaire and do several physical functioning tests while having their trunk and lower limb movement and muscle activation measured.

Conditions

Chronic Low Back Pain (CLBP)

Keywords

movement quality; balance; trunk muscle training

Outcome Measures

Primary Outcomes (8)

• Lower lumbar active range of motion

  active range of motion of the lower lumbar area during five-repetitions sit-to-stand test.

  Same day as first day of intervention and within one week after intervention

• Segmental movement coordination

  Lumbar-to-pelvis and pelvis-to-femur movement coordination as quantified by mean absolute relative phase angle during five-repetitions sit-to-stand. Smaller number indicates greater coordination between the two segments.

  Same day as first day of intervention and within one week after intervention

• Segmental movement stability

  lumbar-to-pelvis and pelvis-to-femur movement stability as quantified by deviation phase during five-repetitions sit-to-stand. Greater number indicates lesser segmental movement stability.

  Same day as first day of intervention and within one week after intervention

• Postural stability

  Center-of-pressure normalized mean velocity during Y-balance test. Smaller number indicate greater stability

  Same day as first day of intervention and within one week after intervention

• Postural Control

  normalized leg reach during y-balance test, with larger number indicating greater postural control.

  Same day as first day of intervention and within one week after intervention

• Perceived pain

  score from numerical pain rating scale from zero (0) to ten (10), with 0 indicating no pain.

  Same day as first day of intervention and within one week after intervention

• Perceived disability

  Score based on oswestry disability index scoring from zero (0) to one hundred (100) percent, with zero indicating no disability.

  Same day as first day of intervention and within one week after intervention

• 5RSTS time

  Time required to complete five-repetitions sit-to-stand with smaller time indicating better performance.

  Same day as first day of intervention and within one week after intervention

Secondary Outcomes (2)

• LAP performance

  Same day as first day of intervention and within one week after intervention

• Muscle synergy

  Same day as first day of intervention and within one week after intervention

Study Arms (3)

Structural Exercise

EXPERIMENTAL

Single armed dumbbell row, push up and single legged deadlift exercises, done three times per week for eight weeks

Behavioral: Structural Exercise

Isolated Trunk Exercise

EXPERIMENTAL

Plank, side bridge, and bird dog isometric holds, done three times per week over eight weeks training

Behavioral: Isolated Trunk Exercise

Control

SHAM COMPARATOR

Back school education where participants are taught about healthy seating position, how to carry loads, and maintaining an active daily lifestyle.

Behavioral: Back school

Interventions

Structural Exercise BEHAVIORAL

Multi-joint limb movement with force vector through the spine. The spine is held at neutral position

Structural Exercise

Isolated Trunk Exercise BEHAVIORAL

Holding the spine in neutral position with no limb movement, with static loading through the spine

Isolated Trunk Exercise

Back school BEHAVIORAL

Patient education that has been proven to not be effective and has been used as control in past low back pain intervention studies

Control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• body mass index (BMI) 18-25 kg/m2
• experiencing intermittent pain lasting at least 3 months
• had Oswestry Disability Index (ODI) score ranging between 17% and 45%.

You may not qualify if:

• exercise contraindication based on physical activity readiness questionnaire
• indication or diagnosis of other chronic diseases (such as cancer, cardiovascular disease, diabetes, bone fracture, or infection)
• artificial lower limb joints, history of spinal surgery, walking aid use
• personal mobility restrictions (due to connective tissue diseases, rheumatoid arthritis, or central nervous system disorders)
• pregnancy or within 1 year post partum

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

Related Publications (5)

• Sutanto D, Ho CY, Wong SHS, Pranata A, Yang Y. Difference in movement coordination and variability during Five-Repetition Sit-to-Stand between people with and without Chronic Low back pain. J Biomech. 2025 Mar;181:112531. doi: 10.1016/j.jbiomech.2025.112531. Epub 2025 Jan 19.

  PMID: 39855104 BACKGROUND

• Sutanto D, Yang YJ, Wong SH. A novel physical functioning test to complement subjective questionnaires in chronic low back pain assessments. Spine J. 2023 Apr;23(4):558-570. doi: 10.1016/j.spinee.2022.12.008. Epub 2022 Dec 17.

  PMID: 36535534 BACKGROUND

• Panjabi MM. The stabilizing system of the spine. Part I. Function, dysfunction, adaptation, and enhancement. J Spinal Disord. 1992 Dec;5(4):383-9; discussion 397. doi: 10.1097/00002517-199212000-00001.

  PMID: 1490034 BACKGROUND

• Sutanto D, Ho RST, Poon ETC, Yang Y, Wong SHS. Effects of Different Trunk Training Methods for Chronic Low Back Pain: A Meta-Analysis. Int J Environ Res Public Health. 2022 Mar 1;19(5):2863. doi: 10.3390/ijerph19052863.

  PMID: 35270557 BACKGROUND

• Chiarotto A, Boers M, Deyo RA, Buchbinder R, Corbin TP, Costa LOP, Foster NE, Grotle M, Koes BW, Kovacs FM, Lin CC, Maher CG, Pearson AM, Peul WC, Schoene ML, Turk DC, van Tulder MW, Terwee CB, Ostelo RW. Core outcome measurement instruments for clinical trials in nonspecific low back pain. Pain. 2018 Mar;159(3):481-495. doi: 10.1097/j.pain.0000000000001117.

  PMID: 29194127 BACKGROUND

Study Officials

• Billy CL So, Prof.

  The Hong Kong Polytechnic University

  STUDY DIRECTOR

Central Study Contacts

Dhananjaya Sutanto, Ph.D.

CONTACT

+852 9680 7397; dhananjaya.sutanto@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-Doctorate Fellow

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 25, 2025
• Study Start: June 1, 2022
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 3 years after the publication of results
• Access Criteria: a proposal that describes planned analyses must be submitted to primary investigator, and once agreed, data sharing agreement would then signed prior to data sharing.

Locations

HK (1)